NCT07173803

The Progressive Supranuclear Palsy Clinical Trial Platform

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Adam Boxer · Academic / Other
• Sex: All
• Age: 41 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of PSP.

Detailed description

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. In this trial, multiple investigational products for PSP will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen. The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting. Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized as outlined for each individual regimen to either study drug or placebo. New regimens will be continuously added as new investigational products become available. PTP will enroll additional participants as each new regimen becomes available. PTP is expected to launch with the following regimen: * Regimen A: AADvac1 * Regimen B: LM11A-31

Conditions

• Progressive Supranuclear Palsy(PSP)

Interventions

Type	Name	Description
BIOLOGICAL	AADvac1	Active immunotherapy
DRUG	LM11A-31	Small molecule

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2025-09-15
• Last updated: 2025-12-02

Regulatory

• FDA-regulated drug study